Kornimate/medical-research-clean huggingface dataset:
effect of passive ultrasonic irrigation versus needle irrigation on postoperative pain and periapical healing

Conditions: Apical Periodontitis

Summary: the aim of this study is to compare the effect of passive ultrasonic irrigation versus needle irrigation on post-operative pain and healing in patients with permanent posterior teeth with apical periodontitis treated in a single visit.

full medical and dental history using a dental chart for all patients treated in this study. clinical and radiographic examination will be done for all patients to verify the diagnosis of apical periodontitis with periapical radiolucency at least 2mm in diameter. the treatment protocol and its associated risks and benefits will be explained to the eligible patients before obtaining informed consent. endodontic procedures will be done in a single visit as follows: access cavity preparation using sterile round bur and endo-z bur, isolation using a rubber dam, canal preparation using a nickel-titanium rotary system then obturation. during mechanical preparation, irrigation will be done using passive ultrasonic irrigation (experimental group) where ultrasonic activation will be done for irrigant-filled canals using the u- file tip (varios nsk) in an ultrasonic device (p5 newtron; satelec acteon) 1mm from the working length after each file change for 10 sec, or needle irrigation (control group) where only the endodontic irrigation needle will be used; the irrigation protocol for each patient will be determined following a random-number sequence.

Eligibility criteria:
inclusion criteria: * age between 18-55 years old. * males and females. * positive patient's acceptance to participate in the study. * mature, permanent, mandibular, posterior teeth with apical periodontitis. exclusion criteria: * medically compromised patients so that no other pain source or drug interaction could interfere with pain resulting from the endodontic therapy. * patients who had received analgesic treatment recently (past 8 hours) as it can affect the results * pregnant females. * teeth with previous root canal treatment.

Keywords: ultrasonic irrigation pain healing apical periodontitis
once weekly parathyroid hormone for osteoporosis

Conditions: Osteopenia; Osteoporosis

Summary: daily parathyroid hormone (pth) is approved by the fda for the treatment of osteoporosis. this study will evaluate the safety and effectiveness of pth when given once a week.

in osteoporosis, skeletal bone mass and strength are so reduced that fractures occur after only modest levels of mechanical stress that would not harm normal bone. fractures of the hip, spine, and wrists are most typical, though fractures of the ribs, pelvis, and humerus also occur. research has shown that hip fractures cause a 10% to 20% increase in mortality, and the cost of all osteoporotic fractures is estimated to be $6.14 billion in health care costs and lost earnings per year. the most common form of osteoporosis is postmenopausal osteoporosis. a reduction in bone mineral density of approximately 1% to 2% per year is observed for the first 3 to 5 years after the onset of menopause, then 0.5% to 1% per year thereafter. pth was recently approved by the fda as a daily treatment for osteoporosis. however, pth must be self-injected, is very expensive, and has been associated with worrisome side effects. the currently approved formulation of daily pth self-injections is practical for only a small proportion of people with osteoporosis. a once weekly formulation could significantly decrease cost, difficulty of administration, and risks and side effects associated with daily use of pth. a once weekly injection by a caregiver would also make pth accessible to populations for whom daily self-injection may not be practical, such as the very elderly or those in assisted living or nursing homes. this study will evaluate the safety and effectiveness of once weekly pth dosing for women with osteoporosis. women will be randomized to receive either pth or placebo. women will self-administer injections daily for 4 weeks, then once weekly for 48 weeks. all women will receive calcium and vitamin d supplements daily. women will visit the clinic six times over the course of a year and will provide urine and blood samples at each visit. bone mineral density will be measured at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * bone mineral density scan with a t-score between -1 and -2 * willing to self-administer injections * postmenopausal exclusion criteria: * medications to treat osteoporosis, including: hormone replacement therapy for more than one month in the 6 months prior to study, or for more than 12 months in the 2 years prior to study; alendronate, risedronate, or etidronate for more than 1 year anytime prior to study; calcitonin in the 3 months prior to study; taken raloxifene or tamoxifen in the last 6 months or for more than 1 year in the 2 years prior to study; fluoride for more than 1 month in the 5 years prior to study * bone fracture since menopause * femoral neck t-score below -2 and lumbar spine t-score below -2.5 or femoral neck t-score below -2.5 and t-scores of both total hip and lumbar spine below -2
it matters: the erectile restoration registry

Conditions: Erectile Dysfunction

Summary: the objective of the it matters registry is to collect real-world data (rwd) to monitor the safe and effective use of commercially available boston scientific corporation (bsc) penile prostheses

it matters is a prospective, multicenter, observational registry that is part of planned, active post market clinical follow-up (pmcf) activity associated with each device. the study will include adult males who undergo penile prothesis implantation with a market approved bsc device to treat erectile dysfunction.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age. 2. males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved bsc penile prothesis by their physician. 3. willing and able to complete the informed consent process. 4. willing and able to comply with the follow-up requirements. exclusion criteria: 1. males who are deemed by their physician as not suitable candidates for a penile prosthesis. 2. in the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.
meningococcal quadrivalent crm-197 conjugate vaccine pregnancy registry

Conditions: Meningococcal Disease; Pregnancy; Infections, Meningococcal

Summary: the glaxosmithkline's meningococcal quadrivalent crm-197 conjugate vaccine pregnancy registry is established to meet a post marketing commitment agreed upon with cber to prospectively collect data on pregnancy exposures to meningococcal quadrivalent crm-197 conjugate vaccine. it is an observational study of women inadvertently immunized with the meningococcal quadrivalent crm-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy as part of routine care. the objective of the pregnancy registry is to evaluate pregnancy outcomes among women immunized with the meningococcal quadrivalent crm-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy. the primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.


Eligibility criteria:
inclusion criteria: * sufficient evidence to confirm that menveo exposure occurred within 28 days prior to conception or at any time during pregnancy * sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry) * date the pregnancy exposure is registered * full reporter (ie, hcp) contact information to allow for follow-up (name, address, etc.) exclusion criteria:
high flow nasal oxygen cannula in transcatheter aortic valve replacement: complications and biomarkers

Conditions: Aortic Stenosis; Sedation Complication

Summary: background transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. the use of hfno could be justified in this context and could improve the results and safety of these procedures. the use of hfno during sedation for tavr could increase oxygen content and minimise hypercapnia, which occurs frequently. this may have 2 potential benefits: one in terms of facilitating the patient's tolerance to anaesthetic sedation; and the other to optimise oxygen delivery to organs such as the brain, kidneys, and myocardium. primary aim the number of oxygen desaturation episodes. an oxygen desaturation episode is defined as any episode of sp02 \<93% for more than 10 seconds. method a single-center prospective randomised controlled clinical trial with 132 individuals comparing the use of high flow nasal oxygen (intervention group) with the conventional standard of care oxygenation with nasal cannula standard oxygenation (control group) of patients undergoing sedation for transfemoral tavr. the randomisation process will be carried out with a 1:1 assignment, using the redcap clínic tool for this purpose. both groups will be treated at the same centre and by the same interventional cardiology and anaesthesia team. sedation regime will be based on target controlled infusion (tci) with propofol and remifentanil. local anaesthesia will be infiltrated by interventional cardiologist prior obtaining femoral vascular access. 50 l/min with 0.6% fio2 will be administered through a high-flow nasal cannula in the intervention group. in the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 l/min.


Eligibility criteria:
inclusion criteria: * all patients \>18 years of age undergoing transfemoral tavr procedure under local anaesthesia and sedation consenting to participate in the study exclusion criteria: * \<18 years and/or refusal to give informed consent for participation general anaesthesia required to perform complex cases of tavr
esophageal balloon calibration in assisted ventilation mode

Conditions: Respiratory Failure; Mechanical Ventilation Pressure High

Summary: esophageal balloon calibration (ebc) has been proposed during controlled mechanical ventilation in intubated patients in order to optimize esophageal pressure (pes) signal. actually, at our knowledge, no data exist about ebc during assisted ventilatory modes such as pressure support ventilation (psv). the primary endpoint of the present investigation is to assess the feasibility of ebc during psv and psv plus sigh.

assisted ventilatory modes, nowadays, have been proved to reduce complications related to controlled mechanical ventilation. with these modes, ventilatory cycling is under the patient's control to an extent depending on the type of ventilatory modality. sigh improves oxygenation and lung mechanics during pressure control ventilation and pressure support ventilation (psv) in patients with acute respiratory distress syndrome. in order to better quantify the effects of both psv and psv plus sigh on respiratory mechanics, the esophageal pressure monitoring could be helpful. however, esophageal pressure (pes) assessment requires esophageal ballon calibration (ebc) as demonstrated in intubated patients under controlled mechanical ventilation. at our knowledge, no data exist about ebc during assisted ventilatory modes. the primary aim of the present study is to evaluate the effects of psv and psv plus sigh ventilation on esophageal balloon best volume in patients admitted to the intensive care unit for acute respiratory failure. .

Eligibility criteria:
inclusion criteria: * patients older than 18 years; * undergoing mechanical ventilation for more than 24 hours (in volume-controlled mode) and with readiness to run assisted ventilation; exclusion criteria: * severe copd with air trapping clinical suspicion; * hemodynamic instability requiring inotropic or vasopressor support; * any contraindications to esophageal catheter positioning

Keywords: esophageal catheter calibration assisted mechanical ventilation
timecost of intranasal versus intravenous analgesia in traumatic pain

Conditions: Acute Pain Due to Trauma; Analgesia

Summary: prehospital treatment of acute traumatic pain is common in military practice. analgesics are usually administered intravenously (iv). research from the civil prehospital environment shows that obtaining iv access can be difficult and time consuming, delaying onset of treatment. the challenges for obtaining iv access in the military prehospital setting are even bigger, for example in combat environments. however, this has not been assessed. current guidelines also offer alternative routes of administration for analgesics, for example intranasal (in) administration. in administration is a fast, easy and effective route of administration. this study determines whether in administration of analgesia is faster and leads to increased healthcare provider satisfaction compared to iv administration in patients with acute traumatic pain in a simulated military prehospital environment.


Eligibility criteria:
inclusion criteria: * all navy healthcare personnel attending (simulation) training on prehospital trauma care. exclusion criteria: none
safety, tolerability, efficacy, and pharmacokinetics of jbt-101 in systemic sclerosis

Conditions: Diffuse Cutaneous Systemic Sclerosis

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of jbt-101 in adult subjects with diffuse cutaneous systemic sclerosis.

part a of the study is an interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of jbt-101 in subjects ≥ 18 and ≤ 70 years of age with active diffuse cutaneous systemic sclerosis. the screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off active treatment. part b of the study is an interventional, open-label design will be used. all subjects who complete dosing in part a without permanent discontinuation of study drug and who pass repeat safety screening will be eligible for enrollment. the screening period is up to 28 days, with a 364 day treatment period and 28 day follow up after last dose of jbt-101.

Eligibility criteria:
inclusion criteria: part a * diffuse cutaneous systemic sclerosis * have skin thickening from ssc in a body area suitable for repeat biopsy * disease duration ≤ 3 years from the first non-raynaud's phenomenon or \>3 years and ≤ 6 years from the first non-raynaud's phenomenon and high sensitivity c-reactive protein \> 3 mg/l, high sensitivity interleukin-6 \> 5 pg/ml, or increase in mrss ≥ 5 points over the last 6 months with total rss ≥ 12. * stable treatment for ssc for at least 28 days before visit 1 part b •completion of dosing in part a without permanent discontinuation of study product because of safety or tolerability reasons. exclusion criteria (part a and b): * severe or unstable systemic sclerosis * significant diseases or conditions other than systemic sclerosis that may influence response to the study product or safety; * any one of the following values for laboratory tests at screening: 1. a positive pregnancy test (or at visit 1); 2. hemoglobin \< 10 g/dl 3. neutrophils \< 1.0 x 10\^9/l 4. platelets \< 75 x 10\^9/l 5. creatinine clearance \< 50 ml/min according to modified cockcroft-gault equation 6. serum transaminases \> 2.0 x upper normal limit 7. total bilirubin ≥ 1.5 x upper limit of normal * any other condition that, in the opinion of the principal investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

Keywords: jbt-101, lenabasum, systemic sclerosis
imatinib in patients with mucosal or acral/lentiginous melanoma

Conditions: Mucosal Melanoma; Acral/Lentiginous Melanoma; Chronically Sun Damaged Melanomas

Summary: the purpose of this study is to evaluate how effective imatinib (gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. imatinib is a protein-kinase inhibitor. it is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.

objectives: primary * to determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib. * to determine the time to progression. secondary * to correlate c-kit mutational status with response to therapy. * to evaluate the use of fdg-pet scanning in determining early biologic response to therapy. * tolerability of imatinib. * to assess amplification of c-kit status through quantitative pcr and/or fish and other related molecular pathway targets. * to correlate c-kit amplification status with response to therapy.

Eligibility criteria:
inclusion criteria: * melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis * history of primary mucosal or acral/lentiginous melanoma * histologically documented stage iv metastatic melanoma * ecog performance status 0,1, or 2 * estimated life expectancy of 6 months or greater * age 18 years or older * creatinine \< 1.5 x uln * anc \> 1500 ul * platelets \> 100,000 ul * total bilirubin, ast, and alt \< 2 x uln * amylase and lipase \< 1.5 x uln * c-kit mutation documented from either primary or metastatic tumor site * \> 4 weeks from prior chemotherapy or investigational drug * at least one measurable site of disease as defined by at least 1 cm in greatest dimension exclusion criteria: * severe and/or uncontrolled medical disease * pregnant or nursing mothers * any other significant medical, surgical, or psychiatric condition that my interfere with compliance * patient is \< 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ * concurrent treatment with warfarin * prior treatment with c-kit inhibitor * patient with grade iii/iv cardiac problems as defined by nyha criteria * no h2 blockers or proton pump inhibitors * known brain metastasis * known chronic liver disease * known diagnosis of hiv infection * previous radiotherapy to \> 25% of the bone marrow * major surgery within 2 weeks prior to study entry * patient has received any other investigational agent within 28 days of first study drug dosing * chemotherapy within 4 weeks prior to study entry

Keywords: imatinib gleevec
montelukast - a treatment choice for covid-19

Conditions: Covid19; SARS-CoV-2 Infection

Summary: the current study aimed to make a therapeutic comparison and effectiveness of hydroxychloroquine (hcq) and montelukast (ml) in covid-19 patients in addition to the standard of care. the safety and efficacy of hcq and ml will be assessed as individual therapy and in combination with each other and with the standard of care. cytokine storm (interleukin levels) also will be monitored throughout the study to assess treatment progression.

to date, no specific medication is available for covid-19. many fda-approved drugs, including antivirals, antibacterials, and anti-inflammatory compositions are being tested with the intention of repurposing against covid-19. in this study, investigators have evaluated the effectiveness of hydroxychloroquine (hcq) and montelukast (ml) in an individual and combination therapy. investigators have performed an observational study of 100 hospitalized covid-19 patients while assessing the safety and efficacy of hcq, ml, and iv as individual therapy and in combination with each other. ecg, interleukin levels, lfts, blood profiles were continuously monitored throughout the study. the aim was to observe participants treated with ml and monitor the inflammatory markers to see whether they increase or decrease and whether an increase in survival rate is observed. the findings have shown that combinational therapy of ml with continuous observation of liver/kidney profiles and qtc prolongation can provide robust recovery with suppression of cytokines.

Eligibility criteria:
inclusion criteria: * patients with diagnosed covid-19 * patients who are not directly admitted to icu exclusion criteria: * patients, who were already on immunosuppressants * patients with age \> 80 * patient with any known allergies to montelukast

Keywords: covid-19 montelukast
a study to assess the efficacy and safety of asp1941 in combination with sulfonylurea in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to evaluate the efficacy and safety after concomitant administration of asp1941 and sulfonylurea in patients with diabetes mellitus.

this study is to evaluate the efficacy and safety of asp1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (t2dm) who have inadequate glycemic control with sulfonylurea alone. the effects of asp1941 are compared with those of placebo. double blind period continues for 24 weeks followed by open period in each patient.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients receiving with sulfonylurea mono-therapy for at least 4 weeks * hba1c value between 7.0 and 9.5% * body mass index (bmi) 20.0 - 45.0 kg/m2 exclusion criteria: * type 1 diabetes mellitus patients * serum creatinine \> upper limit of normal * proteinuria (albumin/creatinine ratio \> 300mg/g) * dysuria and/or urinary tract infection, genital infection * significant renal, hepatic or cardiovascular diseases * severe gastrointestinal diseases

Keywords: diabetes mellitus sulfonylurea asp1941